Regulatory Focus

Top US Food and Drug Administration (FDA) officials said the agency is open to novel, “innovative approaches” to the clinical development of psychedelic drugs in light of the worsening mental health crisis in the US.

The European Medicines Agency (EMA) has updated a guideline on good pharmacovigilance practice (GVP) inspections to reflect changes to the rules on subcontractors.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) has announced the permanent appointment of four top officials to lead the agency's drug, biologics, and tobacco centers, as well as a deputy commissioner for technology and artificial intelligence. The three product center directors were previously serving in those roles in an acting capacity.

The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications (MAA) should provide electronic product information (ePI) for products under the EU's centrally authorized review process. The agency noted that submitting ePI is voluntary until the general pharmaceutical legislation fully goes into effect.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. Several top FDA officials outlined steps they are taking to bolster clinical trial inspections, especially for foreign trials, the agency is seeking input on botanical drugs, and the Department of Health and Human Services (HHS) has issued a new emergency use authorization declaration for military purposes.

Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the types of scientifically valid prior knowledge sponsors may consider when developing gene therapies that involve genome editing to explicitly apply to other types of cell and gene therapies (CGT).